Medical writing: vigilance for ethics
By Robert Hand (robert.hand@rxcomm) As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New…
By Robert Hand (robert.hand@rxcomm) As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New…
By Robert Hand (robert.hand@rxcomms.com) Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky…
The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR.
By Robert Hand (robert.hand@rxcomms.com) For those interested in entering or advancing in the field of health economics and outcomes research, and for those looking for newly-minted researchers to employ, it…
By Robert Hand (robert.hand@rxcomms.com) As a health economist and outcomes researcher, you may work primarily within a single country. Naturally, you know the economic, regulatory, and management issues of that…
By Robert Hand (robert.hand@rxcomms.com) Under the title Legacy of Leadership, the American Medical Writers Association (AMWA) held its 67th Annual Conference on October 11–13 in Atlanta, Georgia. About 1000 medical…
By Robert Hand (robert.hand@rxcomms.com) For a variety of reasons, pharmaceutical manufacturers often do not conduct head-to-head studies of their drugs versus the competition. On the other hand, head-to-head studies are…
By Robert Hand Health economics data play an increasingly important role in getting pharmaceuticals accepted for the drug formularies established by health insurance plans and regulatory authorities. A drug manufacturer…
By Robert Hand In the United States, there has been growing acceptance of the Academy of Managed Care Pharmacy (AMCP) Drug Dossier format for submitting consistent, evidence-based information about drugs.…